Important industry news and company updates

Discovering a new pharmaceutical product or therapy is a process which requires compliance with all Good Clinical Practice (GCP) regulations. However, the complexity of this matter also lies in the fact that in order to obtain the most productive results, researchers need to integrate the most suitable and bias-free methods. Thus, the best implementation as well as assessment of the new drug depend on the so called double-blind randomized controlled trials (DBRCTs). These trials are perceived as the gold standard...MORE >

When we talk about the Pharmaceutical, Medical and Clinical industry, the quality of researches and the outcomes, respectively, are the factors which define the progress as well as the success of these sectors. Meetings, conferences and other similar events are regularly being organized and carried out in order to tackle with an abundance of questions regarding the effects of Good Clinical Practices (GCPs) and their relation to each of the fields mentioned above. One such global meeting, precisely the meeting...MORE >

The very history of clinical studies goes back to 600 B.C and ancient Babylon when the first recorded clinical trial was conducted by Daniel of Judah. What he did was simple but at the same time his report demonstrated significant influence for a jarringly long time – that of more than two millennia. Precisely, Daniel of Judah compared the results and effects of the vegetarian diet with those of the so called royal Babylonian diet. His experiment continued for more...MORE >

All clinical trials are required to be carried out in manners which reflect on Good Clinical Practice (GCP) regulations and demands to ensure patient’s safety and quality of data. However, there are cases when it is hard to find and recruit individuals who are suitable for the purpose of a given study. That is to say that this type of instances are possible to create additional complexities that might turn out to compromise the proper scientific completeness through falsifying data,...MORE >

Clinical trials represent the most expensive, recourse- and time-absorbing component of the whole drug development procedure. Operations within the biopharmaceutical field involve a wide variety of separate operations that include researching, collecting, estimating, systematizing and rationalizing data from a huge volume of sources. In order to ensure efficient Good Clinical Practices (GCPs), regulators urge sponsor organizations to provide a whole-system approach. Such approach will guarantee the well-being of patients and will also serve to orchestrate administrative and operational processes in...MORE >

Many rare diseases are lethal, quickly progressing and debilitating. For this reason the principles of Good Clinical Practice (GCP) and Food and Drug Administration (FDA) regulations ask for adequate and on-time responses which will prevent as many fatal consequences as possible. However, the reality works quite the opposite way. One of the biggest difficulties is the delivery of positive results in a short period of time since clinical trials for rare diseases can take years. This puts at risk a...MORE >

The clinical trial industry is marching towards maturing. However, its advancement confronts stakeholders across the clinical research field with a myriad of challenges. Among the difficulties which stand between sponsors as well as project managers and the completely smooth run of studies are the increasing costs, additional expenses and the constant insisting of regulators to apply more effective monitoring approaches that will guarantee improved Good Clinical Practices (GCPs). One such technique turns out to be risk-based monitoring (RBM). Still, in...MORE >

Developing a brand new pharmaceutical product is lengthy and costly process. For the past several decades it has been indicated that the extensive research does not equal extensive and productive results which turns out to be a real drawback. The lack of sufficient development in the form of new medicines has challenged a number of regulators and researchers to look for advanced methods that will help reduce the unacceptably low level of productiveness. Finding out that the classically structured design...MORE >

There are millions of volunteers who take part in clinical trials every single year. Before participating in any government- or industry-sponsored research, every subject has the right to be informed about what will happen next and how it will happen. Such process in which subject A is provided with the necessary details by subject B is called informed consent. But let’s view this from a slightly larger and more thorough prism. Different trials, of course, carry different risks and/or benefits. Full...MORE >

The idea of innovation circles all around the Pharmaceutical industry. In this sector experts are seeking to develop something new, something working and something that will ostensibly improve life science on a global scale. Still though, the approaches used when carrying out a research could be said to be fairly changed and rather similar to those used more than 20 years ago. And when we talk about progress, such antiqued and familiar procedures are inexcusable. In order to break these...MORE >